The health agency is also asking that companies add warnings for adults and children age 2 and up to oral-health products containing benzocaine, a common ingredient in pain-relieving oral gels, sprays, ointments and lozenges. The FDA has warned companies of legal action if these products are not removed from the market and their sales are not stopped for babies.
New warnings will be added to other benzocaine-containing products for oral use, the agency said. Methemoglobinemia is a unsafe condition that results from elevated levels of methemoglobin, causing oxygen carried through the blood to be reduced, which can ultimately lead to death.
Benzocaine can cause a condition called methmoglobinemia, which can be deadly. Instead, the academy suggests trying teething rings made of firm rubber or massaging a child's gums. Symptoms include a gray or bluish appearance, especially in the lips and nail beds, as well as rapid breathing and an elevated heart rate.
If you can see that the teeth are breaking through the surface, Logan says you can also give your child a small dose of Tylenol. Also, they are not of that much effect, because they can be washed out of the mouth very quickly. Parents should contact their children's doctor for more ways to help their children through the teething process.
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Benzocaine is marketed as a pain reliever for babies who are teething.
Symptoms of methemoglobinemia may begin within minutes and up to two hours after the first use of benzocaine. Inc., which makes Orajel, said it was pulling four Orajel teething products, CBS reported.
FDA commissioner Scott Gottlieb said in a release there are "no demonstrated benefits" from the benzocaine products.
Companies are being urged to voluntarily halt sales of-and parents are being urged to eschew-these sore gum treatments, which are commonly used to treat pain related to teething and other various mouth irritations.
The FDA will also require that prescription local anesthetics for teething children update their product box warnings to let parents know that they too may lead to methemoglobinemia.